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EC number: 203-354-6 | CAS number: 106-02-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 30 October – 7 December 2006
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repetitive insult patch test: 114 human volunteers were topically induced with 9 occluded patches of the test material over a period of 3 weeks followed by a challenge patch after a rest period of 2 weeks and then the application sites were scored for skin irritation.
- GLP compliance:
- no
Test material
- Reference substance name:
- Pentadecan-15-olide
- EC Number:
- 203-354-6
- EC Name:
- Pentadecan-15-olide
- Cas Number:
- 106-02-5
- Molecular formula:
- C15H28O2
- IUPAC Name:
- 1-oxacyclohexadecan-2-one
- Test material form:
- not specified
- Details on test material:
- None
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 114
- Number of subjects completed the study: 105; nine subjects discontinued their participation for various reasons, none of which were related to the application of the test material
- Sex: Male and female
- Age: 17-78 years - Clinical history:
- - Inclusion criteria:
a. Male and female subjects, age 16 and over.
b. Absence of any visible skin disease which might be confused with a skin reaction from the test material.
c. Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
d. Completion of a Medical History form and the understanding and signing of an Informed Consent form.
e. Considered reliable and capable of following directions.
- Exclusion criteria:
a. Ill health.
b. Under a doctor's care or taking medication(s) which could influence the outcome of the study.
c. Females who are pregnant or nursing.
d. A history of adverse reactions to cosmetics or other personal care products. - Controls:
- No
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: Patch test (epicutaneous test)
ADMINISTRATION
- Type of application: Occlusive
- Site: Upper back between the scapulae
- Vehicle: Diethylphthalate/Ethanol: 3:1 (v/v)
- Concentrations: 10 % in vehicle
- Volume applied: 0.2 mL
- Description of patch: Approximately 0.2 mL of the test material, or an amount sufficient to cover the contact surface, was applied to the 3/4" x 3/4" absorbent pad portion of an adhesive dressing. This was then applied to the appropriate treatment site to form an occlusive patch.
- Testing/scoring schedule:
Induction phase: Patches were applied three (3) times per week (e.g., Monday, Wednesday, and Friday) for a total of nine (9) applications. After 24 or 48 h of each application, patches were removed and evaluated for irritation scores.
Challenge phase: Approximately two (2) weeks after the final induction patch application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site, following the same procedure described for induction. The patch was removed and the site scored at the clinic 24 and 72 h post-application.
EXAMINATIONS
- Grading/Scoring system:
0 = No visible skin reaction
+ = Barely perceptible or spotty erythema
1 = Mild erythema covering most of the test site
2 = Moderate erythema, possible presence of mild edema
3 = Marked erythema, possible edema
4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration
Results and discussion
- Results of examinations:
- RESULT OF CASE REPORT: Observations remained within normal limits throughout the test interval.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test material (10 % in diethylphthalate/ethanol: 3:1 v/v), was not considered as a skin sensitiser or irritant in human volunteers.
- Executive summary:
In a repetitive insult patch test, 114 adult male and female human volunteers were topically induced with 9 occluded patches (3 times/week) of 0.2 mL of the test material (10 % in diethylphthalate/ethanol: 3:1 v/v) over a period of 3 weeks, applied on the upper back between the scapulae of each individual. After 24 or 48 h of each application, patches were removed and evaluated for irritation scores. After 2 weeks, a challenge patch was applied to a virgin test site adjacent to the original induction patch site, following the same procedure described for induction. The patch was removed and the site was scored at 24 and 72 h post-application.
Observed skin irritation scores remained within normal limits throughout the test interval.
Under the test conditions, the test material (10 % in diethylphthalate/ethanol: 3:1 v/v), was not considered as a skin sensitiser or irritant in human volunteers.
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